A Phase III Study of Laparoscopy-assisted Versus Open Distal Gastrectomy with Nodal Dissection for Clinical Stage IA/IB Gastric Cancer (JCOG0912)

被引：116

作者：

Nakamura, Kenichi ^{[1
]}

Katai, Hitoshi ^{[2
]}

Mizusawa, Junki ^{[1
]}

Yoshikawa, Takaki ^{[3
]}

Ando, Masahiko ^{[4
]}

Terashima, Masanori ^{[5
]}

Ito, Seiji ^{[6
]}

Takagi, Masakazu ^{[7
]}

Takagane, Akinori ^{[8
]}

Ninomiya, Motoki ^{[9
]}

Fukushima, Norimasa ^{[10
]}

Sasako, Mitsuru ^{[11
]}

机构：

[1] Natl Canc Ctr, Multiinst Clin Trial Support Ctr, JCOG Data Ctr, Operat Off, Tokyo 104, Japan

[2] Natl Canc Ctr, Gastr Canc Div, Tokyo 1040045, Japan

[3] Kanagawa Canc Ctr, Dept Gastrointestinal Surg, Yokohama, Kanagawa 2410815, Japan

[4] Nagoya Univ, Grad Sch Med, Ctr Adv Med & Clin Res, Nagoya, Aichi 4648601, Japan

[5] Shizuoka Canc Ctr, Div Gastr Surg, Mishima, Shizuoka, Japan

[6] Aichi Canc Ctr Hosp, Dept Surg Gastroenterol, Nagoya, Aichi 464, Japan

[7] Shizuoka Prefectural Gen Hosp, Gastroenterol Surg Div, Shizuoka, Japan

[8] Hakodate Goryoukaku Hosp, Dept Surg, Hakodate, Hokkaido, Japan

[9] Hiroshima City Hosp, Dept Surg, Hiroshima, Japan

[10] Yamagata Prefectural Cent Hosp, Dept Surg, Yamagata, Japan

[11] Hyogo Coll Med, Dept Surg, Nishinomiya, Hyogo 6638501, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2013年 / 43卷 / 03期

关键词：

gastric cancer; laparoscopic surgery; gastrectomy; clinical trial; Phase III; TRIAL;

D O I：

10.1093/jjco/hys220

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

A Phase III study was started in Japan to evaluate the non-inferiority of overall survival of laparoscopy-assisted distal gastrectomy with open distal gastrectomy in patients with clinical IA (T1N0) or IB [T1N1 or T2(MP)N0] gastric cancer. This study followed the previous Phase II study to confirm the safety of laparoscopy-assisted distal gastrectomy (JCOG0703) and began in March 2010. A total of 920 patients will be accrued from 33 institutions within 5 years. The primary endpoint is overall survival. The secondary endpoints are relapse-free survival, proportion of laparoscopy-assisted distal gastrectomy completion, proportion of conversion to open surgery, adverse events, short-term clinical outcomes, postoperative quality of life. Only a credentialed surgeon can be responsible for both open distal gastrectomy and laparoscopy-assisted distal gastrectomy.

引用

页码：324 / 327

页数：4

共 8 条

[1]

[Anonymous], 1998, GASTRIC CANCER, V1, P10

[2] Incidence of lymph node metastasis from early gastric cancer: Estimation with a large number of cases at two large centers [J].

Gotoda T. ;

Yanagisawa A. ;

Sasako M. ;

Ono H. ;

Nakanishi Y. ;

Shimoda T. ;

Kato Y. .

Gastric Cancer, 2000, 3 (4) :219-225

[3] Japanese gastric cancer treatment guidelines 2010 (ver. 3) [J].

Sano T. ;

Kodera Y. .

GASTRIC CANCER, 2011, 14 (02) :113-123

[4]

Japanese Gastric Cancer Association, 2001, JAP GASTR CANC TREAT

[5]

Kakizoe T, 2001, CANC STAT JAPAN 2001, P46

[6] Safety and feasibility of laparoscopy-assisted distal gastrectomy with suprapancreatic nodal dissection for clinical stage I gastric cancer: a multicenter phase II trial (JCOG 0703) [J].

Katai, Hitoshi ;

Sasako, Mitsuru ;

Fukuda, Haruhiko ;

Nakamura, Kenichi ;

Hiki, Naoki ;

Saka, Makoto ;

Yamaue, Hiroki ;

Yoshikawa, Takaki ;

Kojima, Kazuyuki .

GASTRIC CANCER, 2010, 13 (04) :238-244

[7]

KITANO S, 1994, SURG LAPAROSC ENDOSC, V4, P146

[8] NOMOGRAMS FOR CALCULATING THE NUMBER OF PATIENTS NEEDED FOR A CLINICAL-TRIAL WITH SURVIVAL AS AN ENDPOINT [J].

SCHOENFELD, DA ;

RICHTER, JR .

BIOMETRICS, 1982, 38 (01) :163-170

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